Dostarlimab、Dostarlimab subcutaneous injection(Tesaro)、Immunoglobulin G4, anti-programmed cell death protein 1 (PDCD1) (humanized clone ABT1 gamma4-chain), disulfide with humanized clone ABT1 kappa-chain, dimer

+ [12]

靶点

PD-1

作用方式

抑制剂

作用机制

PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤泌尿生殖系统疾病神经系统疾病+ [9]

在研适应症

晚期子宫内膜癌复发性子宫内膜癌MSI-H 实体瘤+ [77]

非在研适应症

晚期胆管癌晚期非小细胞肺癌透明细胞肉瘤+ [7]

原研机构

AnaptysBio, Inc.

在研机构

Tesaro, Inc.

GSK PlcGlaxoSmithKline Research & Development Ltd.

+ [6]

非在研机构-

权益机构

AnaptysBio, Inc.Sagard Healthcare Royalty Partners LP

GSK Plc

+ [1]

最高研发阶段批准上市

首次获批日期

欧盟 (2021-04-21),

错配修复缺陷子宫内膜癌

最高研发阶段(中国)临床3期

特殊审评快速通道 (美国)、加速批准 (美国)、优先审评 (澳大利亚)、优先审评 (美国)、局长国家优先审评券 (美国)、突破性疗法 (美国)

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结构/序列

Sequence Code 315609369H

来源: *****

Sequence Code 315609370L

来源: *****

关联

114

项与多塔利单抗相关的临床试验

NCT07740720

/ Not yet recruiting临床3期

A Phase 3b, Open-label Study Investigating the Duration of Neoadjuvant Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer

This study is conducted in adults with rectal cancer that has a certain genetic type. The main goal is to find out whether a longer treatment period with dostarlimab can help more participants have a complete response to treatment and avoid standard treatments like chemotherapy, radiation treatment, or surgery. Scans and endoscopy tests will be conducted to see if the tumor disappears and how long the cancer stays under control. The study will also collect information on side effects and health outcomes after dostarlimab.

开始日期2026-09-17

申办/合作机构

GSK Plc

NCT07684599

/ Not yet recruiting临床3期

A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan in Combination With Immune Checkpoint Inhibition for Maintenance Treatment of Participants With Mismatch Repair Proficient (MMRp) Endometrial Cancer

The purpose of this study is to see how well mocertatug rezetecan (Mo-Rez) in combination with physician's choice of immunotherapy (dostarlimab or pembrolizumab) works as maintenance therapy in participants with advanced or recurrent endometrial cancer (EC) compared with the physician's choice of immunotherapy (dostarlimab or pembrolizumab) alone, which represents the current standard of care. The study will also assess whether the drug combination is safe and tolerated well by participants compared to standard of care and will help us better understand its impact on Health-Related Quality of Life of participants.

开始日期2026-09-03

申办/合作机构

GSK Plc

NCT07652515

/ Not yet recruiting临床4期

Phase 4, Open Label, Single-arm, Interventional, Multicenter Study to Evaluate the Safety of Dostarlimab in Adult Patients in India With Primary Advanced or Recurrent Endometrial Cancer

This study will evaluate the safety of dostarlimab in combination with carboplatin and paclitaxel followed by monotherapy when administered as a first-line treatment in advanced or recurrent endometrial cancer (EC).

开始日期2026-08-17

申办/合作机构

GSK Plc

100 项与多塔利单抗相关的临床结果

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100 项与多塔利单抗相关的转化医学

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100 项与多塔利单抗相关的专利（医药）

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223

项与多塔利单抗相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Estimating the budget impact of introducing dostarlimab as first line in treating endometrial cancer in Saudi Arabia

Article

作者: Hassan, Mohamed El-Khedr ; Alanazi, Ahmed S. ; Masoud, Mohamed ; Aseafan, Mohamed ; Soliman, Hany ; Azam, Faisal ; Alsharef, Zainab ; Almalki, Nawaf H. ; Alhumaid, Shaheed

OBJECTIVE:

The budget impact of introducing dostarlimab plus carboplatin-paclitaxel (CP) as a first-line treatment option for primary advanced or recurrent endometrial cancer (EC) in Saudi Arabia was evaluated from the perspective of the Saudi national payer.

METHODS:

The budget impact model (BIM) utilized epidemiological, clinical, and cost and resource use inputs to evaluate the total costs associated with a market scenario without dostarlimab versus a market scenario with dostarlimab over a three-year time horizon (2026-2028). Currently available comparator treatments in Saudi Arabia were evaluated based on associated market share and relevance as comparable treatment regimens to dostarlimab plus CP. A one-way sensitivity analysis was performed to identify the sensitivity of the BIM to changes in input parameters.

RESULTS:

Out of 250 eligible patients, 58 were estimated to receive dostarlimab plus CP as a first-line EC treatment during its first year on the market, increasing to 242 out of 569 eligible patients in the third year. The resulting annual budget impact was -$326,607 in the first year and -$668,830 in the third year of market availability, with a total cumulative budget impact of -$1,650,171 over the three-year time horizon. The mean annual budget impact per patient treated with dostarlimab plus CP was -$4,388.57, a decrease of -1.84% compared with the scenario without dostarlimab.

CONCLUSIONS:

The introduction of dostarlimab plus CP to healthcare settings for first-line treatment of primary advanced and recurrent EC was found to be budget neutral in this model, with lower treatment acquisition costs and decreased second-line subsequent treatment costs compared with the other currently available treatment options.

2026-12-31·PLATELETS

Immune thrombocytopenia triggered by dostarlimab in a patient with endometrial carcinoma: first reported case

Article

作者: Pazmiño-Zambrano, M. Belén ; García-Jaén, Pablo ; González-Porras, José Ramón ; Bastida, José María ; Fernández-Sánchez, Adolfo ; Reguera-Puertas, Pablo ; Puerta-Vázquez, Carlos

Immune checkpoint inhibitors (ICIs) have transformed the treatment landscape for various malignancies, but they are associated with a range of immunerelated adverse events, including rare hematological complications. Immune thrombocytopenia (ITP) has been reported with other antiPD1 agents such as nivolumab and pembrolizumab, but to date, no cases have been described with dostarlimab. We report the first case of ITP in a patient receiving dostarlimab for relapsed endometrial carcinoma. A 55yearold woman developed severe thrombocytopenia (3 × 10⁹/L) accompanied by rectal bleeding, resulting in a lifethreatening condition. Secondary causes were excluded, and bone marrow findings supported a diagnosis of ITP. Initial treatment with highdose corticosteroids and intravenous immunoglobulin achieved only a partial response, while sustained platelet recovery was obtained with the addition of romiplostim. The patient remained on dostarlimab following hematological recovery without further episodes of ITP. This case highlights a potentially lifethreatening adverse effect of a widely used immunotherapy and underscores the importance of early recognition and timely escalation of treatment in ICIinduced ITP.

2026-09-01·CANCER LETTERS

Frontline immunotherapy and immune cold reprogramming across molecular subtypes of advanced endometrial cancer

Review

作者: Li, Chia-Jung ; Wen, Zhi-Hong ; Raj, Emmanuel Naveen ; Cheng, Shih-Hsuan ; Lin, Pei-Hsuan ; Sheu, Jim Jinn-Chyuan ; Chang, Renin ; Chiang, An-Jen

The management of endometrial cancer (EC) has transitioned from a histopathological model to a framework based on molecular precision. This change is centered on the integration of immune checkpoint inhibitors, which has altered clinical standards for different genomic subsets. For patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) tumors, PD-1 and PD-L1 blockade has moved from late-line therapy to a frontline standard. Results from the RUBY and NRG-GY018 trials show that combining dostarlimab or pembrolizumab with platinum-based chemotherapy improves survival in patients with untreated advanced disease. Mismatch repair proficient (pMMR) tumors, which make up the majority of cases, remain difficult to treat due to an immune-cold microenvironment. Overcoming this resistance requires combination strategies, such as using anti-angiogenic agents like lenvatinib with immune checkpoint inhibitors, as shown in the KEYNOTE-775 trial. Data from the DUO-E study also suggest that including DNA damage response inhibitors may improve results in pMMR populations. As molecular monitoring via liquid biopsy and the use of antibody-drug conjugates (ADCs) evolve, the personalization of immunotherapy continues to progress. This review examines current clinical evidence and the mechanisms of resistance to define the future of precision medicine in endometrial cancer.

700

项与多塔利单抗相关的新闻（医药）

2026-09-23

·SK盛康医疗

全球医药前沿动态汇总：免疫肿瘤、创新药研发进展

01 肿瘤领域默沙东 KEYTRUDA QLEX 皮下注射制剂扩大至帕博利珠单抗全部已获批适应症默沙东公布，帕博利珠单抗皮下注射制剂 KEYTRUDA QLEX 获批扩展适应症，覆盖静脉版帕博利珠单抗既往全部获批肿瘤适应症。相比静脉输注，皮下注射可显著缩短给药时长，适用于多种实体瘤、部分血液肿瘤；药品依旧需要严格遵循肿瘤生物标志物筛选，该制剂已经纳入当地医保支付评估流程。AnaptysBio 公布 Jemperli 半年销售数据，AZUR‑1 关键试验中期积极数据披露 AnaptysBio 发布 2026 上半年财报，PD‑1 抑制剂 Jemperli 全球半年净销售额 6.44 亿美元，同比增长 34%。同时披露 AZUR‑1 关键 II/III 期试验中期积极结果，该试验评估 Jemperli 用于局部晚期直肠癌；企业另有自身免疫疾病管线，将集中资源推进自身免疫疾病注册试验，肿瘤管线除本次 AZUR-1 数据外暂无其他新临床读出数据。 02 新药研发领域 Alkermes 公布 ADHD 候选药物 ALKS7290 Ib 期积极临床概念验证结果 ALKS7290 为用于成人注意力缺陷多动障碍（ADHD）的口服候选药物，Ib 期研究达到概念验证终点。试验观察到受试者注意力相关量表指标改善，整体安全性可管控；企业计划推进 II 期注册临床试验，该产品尚未递交上市申请。Diasome 将在 EASD 2026 大会公布 HDV‑Insulin IIb 期完整临床数据 HDV‑Insulin 为肝脏靶向递送胰岛素制剂，用于 1 型糖尿病。企业宣布将在欧洲糖尿病研究协会 EASD 年会披露 IIb 期完整疗效与安全性数据；该技术旨在提升胰岛素向肝脏靶向富集，减少外周高胰岛素相关不良反应，目前处于临床开发阶段，未提交上市申报。核验备注：同期药监审评公示专栏，除上述默沙东皮下制剂适应症扩大外，无其余新药批准、新增适应症批复；无药品说明书修订、药物安全警示通告对外发布，无可核验其他新增公开资讯。 03 再生医疗与基础科研领域 Tiziana 公司，鼻腔给药 Foralumab 多发性硬化 IIa 期 INFORM‑MS 试验完成最后一例受试者末次访视鼻腔给药抗 CD3 抗体 Foralumab 用于复发缓解型多发性硬化，IIa 期 INFORM‑MS 研究完成全部受试者随访。Foralumab 通过鼻腔黏膜给药，旨在调节中枢相关自身免疫反应；完整试验数据集将后续学术会议对外公布，产品处于临床早期，尚未启动注册 III 期试验。本文所有资讯内容均来源于公开官方公告、权威行业媒体公开报道，仅用于行业信息交流、产业研究、学习参考，不构成任何投资建议、临床诊疗指导及商业决策依据。文中涉及的药物研发进度、临床试验数据、药监审批结果及市场动态均以原文发布机构官方最新公示为准，整理内容仅做合规梳理与精简优化，不保证信息绝对实时性与完整性。未经授权严禁私自篡改、商用、转载及二次营销使用，如有信息疏漏、更新或更正需求，以官方原始溯源链接内容为准。

2026-09-22

·ioncology

ESMO 2026丨LBA重磅发布！头颈肿瘤与黑色素瘤领域最新进展一文纵览！

编者按：2026年欧洲肿瘤内科学会（ESMO）年会将于当地时间10月23日至27日在西班牙马德里举办。本届大会汇聚全球肿瘤领域的顶尖专家与临床研究者，集中呈现各瘤种的前沿研究成果与诊疗突破，为推动全球抗肿瘤事业的发展持续输送循证动力。继大会常规摘要公布之后，本届ESMO的突破性摘要（Late-Breaking Abstract，LBA）名单与口头报告日程已正式发布。头颈肿瘤与黑色素瘤两大领域共有多项重磅研究入选口头报告专场（Proffered Paper Session）与快速口头报告专场（Rapid Oral），其中中国学者主导的多项研究也将在本次大会上亮相。本文整理了该领域口头报告的研究题目与关键信息，带您提前预览本次ESMO大会的部分亮点。黑色素瘤（一） Presidential Symposium I（主席研讨会I）日期：2026年10月24日地点：Alicante Auditorium - Hall 6 时间：16:30 - 18:15 LBA1 INTerpath-001: Phase 3 study of the mRNA-based individualized neoantigen therapy (INT) intismeran autogene (intismeran) plus pembrolizumab (pembro) vs pembro alone for adjuvant treatment of resected stage IIB-IV melanoma (MEL) INTerpath-001 III期研究：mRNA个体化新抗原疗法intismeran autogene联合帕博利珠单抗对比帕博利珠单抗单药辅助治疗已切除IIB-IV期黑色素瘤讲者：Georgina V. Long（澳大利亚）（二）Proffered paper: Melanoma and other skin tumours（口头报告专场：黑色素瘤与其他皮肤肿瘤）日期：2026年10月23日地点：Barcelona Auditorium - Hall 9 时间：16:15 - 17:45 2071O STARBOARD Phase 3: A randomized, double-blind study of first-line (1L) encorafenib (enco), binimetinib (bini), and pembrolizumab (pembro) vs placebo (pbo) and pembro for unresectable locally advanced or metastatic BRAF V600-mutant melanoma STARBOARD III期研究：恩考芬尼+比美替尼+帕博利珠单抗对比安慰剂+帕博利珠单抗一线治疗不可切除局部晚期或转移性BRAF V600突变黑色素瘤的随机双盲研究讲者：Dirk Schadendorf（德国） LBA54 Primary Analysis of HBI-8000-303: A Randomized Phase 3 Trial of Nivolumab plus HBI-8000 or Placebo in Advanced Melanoma HBI-8000-303研究主要分析：纳武利尤单抗联合HBI-8000或安慰剂治疗晚期黑色素瘤的随机III期试验讲者：Nikhil I. Khushalani（美国） 2072O Efficacy and Safety of Lifileucel and Pembrolizumab in Patients with Immune Check Point Inhibitor-Naïve Advanced Melanoma - Final Results from IOV-COM-202 Study IOV-COM-202研究最终结果：Lifileucel联合帕博利珠单抗治疗免疫检查点抑制剂初治晚期黑色素瘤的疗效与安全性讲者：Andrew J. Furness（英国） LBA55 Autologous Tumor-Infiltrating Lymphocytes (GC101 TIL) in Advanced Melanoma: Extended Followup of a Randomized, Open-Label, Pivotal Phase II Trial 自体肿瘤浸润淋巴细胞（GC101 TIL）治疗晚期黑色素瘤：一项随机、开放标签、关键性II期试验的延长随访结果讲者：斯璐教授（北京大学肿瘤医院）（三）Rapid oral: Melanoma and other skin tumours（快速口头报告专场：黑色素瘤与其他皮肤肿瘤）日期：2026 年 10 月 25 日（周日）地点：Granada Auditorium - Hall 4 时间：10:15 - 11:45 2073RO Patritumab Deruxtecan (HER3-DXd) in Melanoma After Anti-PD-(L) 1 Therapy: Primary Analysis From HERTHENA-PanTumor01 HERTHENA-PanTumor01研究主要分析：Patritumab Deruxtecan（HER3-DXd）治疗经抗PD-(L) 1抑制剂治疗后黑色素瘤患者的疗效讲者：Meredith McKean（美国） 2074RO Enfortumab Vedotin (EV) plus Pembrolizumab (P) for Refractory Advanced Melanoma: Primary Results from the PLUG-IN GEM 2301 Trial PLUG-IN GEM 2301试验主要结果：维恩妥尤单抗联合帕博利珠单抗治疗难治性晚期黑色素瘤讲者：Guillermo De Velasco（西班牙） 2075RO Phase 1 dose expansion of a tetravalent CD137/PD-L1 bispecific antibody (FS222) in PD-1 inhibitor-resistant melanoma patients. 四价CD137/PD-L1双特异性抗体（FS222）治疗PD-1抑制剂耐药黑色素瘤患者的I期剂量扩展研究讲者：Guillermo De Velasco（西班牙） 2076RO Three-year distant metastasis-free survival of the phase 3 NADINA trial comparing neoadjuvant nivolumab plus ipilimumab versus adjuvant nivolumab in resectable stage III melanoma NADINA III期研究3年无远处转移生存结果：可切除III期黑色素瘤新辅助纳武利尤单抗+ 伊匹木单抗对比辅助纳武利尤单抗治疗讲者：Sonja Witteveen（荷兰）（四）Rapid oral 2: Basic science and translational research（快速口头报告专场 2：基础科学与转化研究）日期：2026年10月26日地点：Cordoba Auditorium - Hall 4 时间：10:15 - 11:45 4250RO High affinity FcγR3A germline SNP impairs outcome upon anti-PD1 in melanoma 高亲和力FcγR3A胚系单核苷酸多态性对黑色素瘤患者抗PD-1治疗结局的影响讲者：Steven Wijnen（荷兰） 4251RO Humoral immunity against melanocytic differentiation antigens associates with benefit from immune checkpoint blockade in melanoma 抗黑素细胞分化抗原的体液免疫与黑色素瘤患者免疫检查点抑制剂治疗获益的相关性讲者：Lukas Flatz（德国）头颈肿瘤（一）Proffered paper: Head and neck cancer（口头报告专场：头颈肿瘤）日期：2026年10月25日地点：Madrid Auditorium - Hall 4 时间：08:30 - 10:00 LBA42 HexAgon-HN: a phase 2/3 study of the hexavalent OX40 agonist ordastobart (INBRX-106) in combination with pembrolizumab as first-line treatment (1L tx) of PD-L1–high recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC)—phase 2 primary analysis HexAgon-HN研究II期主要分析：六价OX40激动剂 ordastobart（INBRX-106）联合帕博利珠单抗一线治疗PD-L1高表达复发/转移性头颈部鳞状细胞癌的II/III期研究讲者：Jong Chul Park（美国） LBA43 Tam-Peli versus chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): a multicenter, randomized, open-label, phase 3 study (TAISHAN-301) TAISHAN-301研究：Tam-Peli对比化疗治疗多线治疗后复发/转移性鼻咽癌的多中心、随机、开放标签III期研究讲者：洪少东教授（中山大学肿瘤防治中心） LBA44 TPF versus a novel regimen of paclitaxel, carboplatin, and oral metronomic chemotherapy as neoadjuvant treatment for technically unresectable oral cancers: multicentric phase III randomized non-inferiority study 多中心III期随机非劣效性研究：TPF方案对比紫杉醇+卡铂+口服节拍化疗新辅助治疗技术上不可切除口腔癌的疗效讲者：Vanita Noronha（印度） LBA45 Quality of life after primary TORS vs IMRT for patients with early-stage oropharyngeal squamous cell carcinoma (QoLATI/DAHANCA34): a multicentre, open-label, randomised phase 2 trial QoLATI/DAHANCA34研究：早期口咽鳞状细胞癌患者接受经口机器人手术对比调强放疗后的生活质量：一项多中心、开放标签、随机II期试验讲者：Hani I. Channir（丹麦） 1535O Comparable Swallowing Function at 12 Months but Divergent Toxicity Profiles with TOS versus DO-IMRT in Early-Stage Oropharyngeal, Supraglottic and Hypopharyngeal Carcinoma: Primary Results of the Phase III EORTC 1420 'Best-of' Trial EORTC 1420"Best-of"III期研究主要结果：早期口咽、声门上及下咽癌患者接受TOS对比DO-IMRT治疗后12个月吞咽功能相当但毒性特征存在差异讲者：Christian Simon（瑞士）（二）Rapid oral: Head and neck cancer（快速口头报告专场：头颈肿瘤）日期：2026年10月25 日地点：Madrid Auditorium - Hall 4 时间：14:45 - 16:15 LBA46 Niraparib and dostarlimab plus radiotherapy (RT) in locally advanced head and neck squamous cell carcinoma (LA-HNSCC) patients (TTCC-2022-01 RADIAN). RADIAN（TTCC-2022-01）研究：尼拉帕利+多塔利单抗联合放疗治疗局部晚期头颈部鳞状细胞癌患者讲者：Marc Oliva（西班牙） 1536RO ctDNA analysis of the phase 3 KEYNOTE-412 trial: pembrolizumab (pembro) or placebo (pbo) + concurrent chemoradiotherapy (CRT) for locally advanced head and neck squamous cell carcinoma (LA HNSCC) KEYNOTE-412 III期研究ctDNA分析：帕博利珠单抗或安慰剂联合同步放化疗治疗局部晚期头颈部鳞状细胞癌讲者：Jean-Pascal Machiels（比利时） 1537RO A single-arm, multi-institutional, phase 2 study of a pembrolizumab-based organ preservation strategy for locally advanced larynx cancers: SMART-KEY (LACOG 0720) SMART-KEY（LACOG 0720）研究：帕博利珠单抗为基础的器官保留策略治疗局部晚期喉癌的单臂、多中心II期研究讲者：Thiago B. Oliveira（巴西） 1539RO Amivantamab + pembrolizumab + carboplatin in first-line recurrent/metastatic head & neck squamous cell cancer (1L R/M HNSCC): Results from the phase 1b/2 OrigAMI-4 study OrigAMI-4研究Ib/II期结果：埃万妥单抗+帕博利珠单抗+卡铂一线治疗复发/转移性头颈部鳞状细胞癌讲者：Paul L. Swiecicki（美国） 1542RO Phase II Study of Izalontamab Brengitecan (iza-bren) Plus Pembrolizumab in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) 伦康依隆妥单抗（iza-bren）联合帕博利珠单抗治疗复发/转移性头颈部鳞状细胞癌的 II 期研究讲者：季冬梅教授（复旦大学附属肿瘤医院） 1540RO A phase II trial of neoadjuvant nivolumab, docetaxel, and cisplatin followed by surgery and radiation therapy for resectable high-grade salivary gland carcinoma 新辅助纳武利尤单抗+多西他赛+顺铂序贯手术及放疗治疗可切除高级别涎腺癌的II期试验讲者：Sehhoon Park（韩国） LBA47 A Prospective, Randomized, Phase II Study of Perioperative Tislelizumab with Chemotherapy in Patients with Locally Advanced Resectable Oral Squamous Cell Carcinoma (OPTIMAL study) OPTIMAL研究：替雷利珠单抗围手术期联合化疗治疗局部晚期可切除口腔鳞状细胞癌的前瞻性、随机II期研究讲者：何悦教授（上海交通大学医学院附属第九人民医院） 1538RO First Interim Safety analysis of GORTEC 2024-03 IDEAL: randomized phase II trial of induction treatment anti–PD-1 pucotenlimab (HX008) plus EGFR-ADC (becotatug vedotin (MRG003) versus EGFR-ADC alone followed by chemoradiotherapy in locally advanced head and neck squamous cell carcinoma GORTEC 2024-03 IDEAL研究首次中期安全性分析：抗PD-1单抗普特利单抗（HX008）联合EGFR-ADC（维贝柯妥塔单抗，MRG003）诱导治疗对比EGFR-ADC单药序贯放化疗治疗局部晚期头颈部鳞状细胞癌的随机II期试验讲者：陶运淦教授（法国） 1541RO Perioperative Cetuximab combined with Toripalimab for Locally Recurrent Resectable Head and Neck Squamous Cell Carcinoma: A Prospective, Single-arm, Phase II Study 围手术期西妥昔单抗联合特瑞普利单抗治疗局部复发可切除头颈部鳞状细胞癌的前瞻性、单臂II期研究讲者：鞠侯雨教授（上海交通大学医学院附属第九人民医院）（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果临床2期信使RNAASCO会议临床3期

2026-09-22

·ioncology

ESMO 2026丨LBA重磅发布！消化道肿瘤领域研究抢先预览

点击蓝字关注我们编者按 2026年欧洲肿瘤内科学会（ESMO）年会将于10月23~27日在西班牙马德里盛大召开，目前大会官网已经公布万众期待的LBA（Late‑Breaking Abstract，最新突破性摘要）完整列表。消化道肿瘤依旧是本届ESMO的热点板块，覆盖胃食管肿瘤、胆道肿瘤、结直肠癌、肝癌、胰腺癌、食管癌多个癌种，ADC新药、免疫联合方案、围手术期策略优化、AI辅助多学科决策、营养干预等方向均产出关键临床结果，同时多项来自中国的原创临床研究荣登LBA舞台，代表中国力量走向国际。本文对消化道肿瘤相关LBA按癌种分类整理，带大家提前一睹本届大会消化道领域的重磅看点。胃食管肿瘤摘要号：LBA7 英文标题：CLARITY-Gastric 01 (CG-01): a Phase 3 study of sonesitatug vedotin (Sone-Ve) in second or later-line (2L+) advanced or metastatic Claudin 18.2 (CLDN18.2) positive gastroesophageal carcinoma (GEC) 中文标题：CLARITY-Gastric 01（CG-01）：Sonesitatug vedotin（Sone-Ve）二线及以上(2L+)治疗Claudin 18.2阳性晚期/转移性胃食管癌的Ⅲ期研究讲者：徐瑞华｜中山大学肿瘤防治中心摘要号：LBA77 英文标题：Arcotatug tavatecan (IBI343/TAK-921) versus treatment of physician’s choice (TPC) in previously treated, advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA): First interim analysis of the randomized, open-label, phase 3, G-HOPE-001 study 中文标题：Arcotatug tavatecan（IBI343/TAK‑921）对比研究者选择方案用于经治晚期胃癌/胃食管结合部腺癌：随机开放标签Ⅲ期G-HOPE-001研究首次中期分析讲者：Kohei Shitara｜Kashiwa, Japan, Chiba 摘要号：LBA80 英文标题：Anbenitamab plus chemotherapy for previously treated HER2-positive gastric or gastroesophageal carcinomas (GC/GEJC): Updated overall survival (OS) analysis of KC-WISE 中文标题：安尼妥单抗联合化疗用于经治HER2阳性胃/胃食管癌：KC-WISE研究更新总生存期（OS）结果讲者：徐建明｜解放军总医院第一医学中心摘要号：LBA81 英文标题：Four Months of Adjuvant XELOX versus Six Months in Stage II–IIIB Gastric Cancer — The LOMAC Randomized Trial 中文标题：Ⅱ~ⅢB期胃癌XELOX辅助化疗4个月对比6个月疗效：LOMAC随机临床研究讲者：徐大志｜复旦大学肿瘤医院胆道肿瘤摘要号：LBA8 英文标题：Ivonescimab plus chemotherapy versus durvalumab plus chemotheray as first-line treatment for advanced biliary tract cancer: a randomized, controlled, double- blinded, phase 3 trial (HARMONi-GI1) 中文标题：依沃西单抗联合化疗对比度伐利尤单抗联合化疗一线治疗晚期胆道癌：随机、对照、双盲Ⅲ期HARMONi-GI1研究讲者：周俭｜复旦大学附属中山医院摘要号：LBA21 英文标题：Adjuvant chemotherapy with gemcitabine and cisplatin compared to standard of care after curative intent resection of cholangiocarcinoma and gallbladder carcinoma (ACTICCA-1 trial) 中文标题：吉西他滨联合顺铂辅助化疗对比标准治疗用于胆管癌及胆囊癌根治性切除术后：ACTICCA-1研究讲者：Henning Wege｜Hamburg, Germany 摘要号：LBA22 英文标题：OPTIMUM: A randomized phase 2 study of maintenance olaparib (Ola) with or without durvalumab (Durva) in DDR gene-mutated advanced biliary tract cancer (aBTC) 中文标题：OPTIMUM：DDR基因突变型晚期胆道癌采用奥拉帕利维持治疗联合/不联合度伐利尤单抗的随机Ⅱ期研究讲者：Changhoon Yoo｜Seoul, Republic of Korea, Songpa-gu 结直肠癌摘要号：LBA18 英文标题：AI for Robust Decision Support for Multidisciplinary Colorectal Cancer Team Meetings 中文标题：人工智能为结直肠癌多学科会诊提供可靠临床决策支持讲者：Shazad Ashraf｜Birmingham, United Kingdom 摘要号：LBA29 英文标题：IROCAS: A randomized phase III trial of adjuvant treatment intensification with mFOLFIRINOX versus mFOLFOX6 in high-risk stage III (T4 and/or N2) colon cancer 中文标题：IROCAS：高危Ⅲ期（T4和/或N2）结肠癌mFOLFIRINOX强化辅助治疗对比mFOLFOX6的随机Ⅲ期研究讲者：Jaafar Bennouna｜Suresnes, France 摘要号：LBA30 英文标题：Omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA) versus placebo after resection of colorectal cancer liver metastases (EMT2): A multicentre, double-blind, randomised phase 3 trial 中文标题：结直肠癌肝转移切除术后Omega-3多不饱和脂肪酸EPA对比安慰剂：多中心双盲随机Ⅲ期EMT2研究讲者：Mark A. Hull｜Leeds, United Kingdom 摘要号：LBA31 英文标题：Biweekly versus conventional trifluridine/tipiracil plus bevacizumab for refractory metastatic colorectal cancer: the pragmatic phase 3 PRABITAS trial 中文标题：双周方案对比常规方案三氟胸苷/替匹嘧啶联合贝伐珠单抗治疗难治性转移性结直肠癌：实用性Ⅲ期PRABITAS研究讲者：Hiroya Taniguchi｜Nagoya, Japan, Aichi 摘要号：LBA32 英文标题：Final overall survival results from CheckMate 8HW: nivolumab plus ipilimumab versus nivolumab or chemotherapy in MSI-H/dMMR metastatic colorectal cancer 中文标题：CheckMate 8HW最终总生存结果：纳武利尤单抗联合伊匹木单抗对比纳武利尤单抗单药或化疗用于MSI-H/dMMR转移性结直肠癌讲者：Sara Lonardi｜Padua, Italy 摘要号：LBA87 英文标题：Clinical Complete Response With Dostarlimab Monotherapy in dMMR/MSI-H Locally Advanced Rectal Cancer (LARC): First Results From the Global Registrational AZUR-1 Trial 中文标题：dMMR/MSI-H局部晚期直肠癌接受多塔利单抗单药治疗获得临床完全缓解：全球注册AZUR-1研究首次结果讲者：Andrea Cercek｜New York, United States of America, NY 肝细胞癌摘要号：LBA48 英文标题：Liver function trajectory and post-progression outcomes in the Phase 3 EMERALD-3 study of tremelimumab (T) + durvalumab (D) ± lenvatinib (L) + transarterial chemoembolisation (TACE) in participants (pts) with embolisation-eligible hepatocellular carcinoma (eeHCC) 中文标题：可栓塞肝细胞癌患者中，tremelimumab(T)+度伐利尤单抗(D)±仑伐替尼(L)联合TACE的Ⅲ期EMERALD-3研究：肝功能轨迹及进展后结局讲者：Masatoshi Kudo｜Osaka, Japan 食管癌摘要号：LBA78 英文标题：Active surveillance versus standard surgery after neoadjuvant chemoradiotherapy for oesophageal cancer: long-term results of a cluster-randomised controlled trial (SANO) 中文标题：食管癌新辅助放化疗后主动监测对比标准手术治疗：整群随机对照SANO研究长期随访结果讲者：Sanjiv S. Gangaram-Panday ｜Rotterdam, Netherlands 胰腺癌摘要号：LBA82 英文标题：Daraxonrasib, a RAS(ON) multi-selective inhibitor vs chemotherapy in previously treated metastatic pancreatic adenocarcinoma (mPDAC): Additional subgroup analyses from the Ph3 RASolute 302 study 中文标题：RAS(ON)多选择性抑制剂Daraxonrasib对比化疗用于经治转移性胰腺导管腺癌：Ⅲ期RASolute302研究补充亚组分析讲者：Zev A. Wainberg ｜Los Angeles, United States of America 摘要号：LBA83 英文标题：Seven-Valent mKRAS-specific Lymph Node Targeted Amphiphile Immunotherapy Versus Observation in Resected Pancreatic Ductal Adenocarcinoma (PDAC): the AMPLIFY-7P randomized Phase 2 study 中文标题：七价mKRAS特异性淋巴结靶向两亲性免疫治疗与观察疗法在已切除胰腺导管腺癌中的疗效对比：AMPLIFY-7P随机Ⅱ期研究讲者：Eileen M. O'Reilly｜New York, United States of America 摘要号：LBA84 英文标题： A randomized, multicenter, open-label, double-arm, phase III study of doublet vs. monotherapy in advanced pancreatic cancer patients who have failed first-line therapy. (Panc-SELECT - Gemcitabine arms) 中文标题：一线治疗失败晚期胰腺癌，双药对比单药治疗的随机、多中心、开放标签、双臂Ⅲ期研究（Panc-SELECT——吉西他滨队列）讲者：Prabhat G. Bhargava｜Mumbai, India 摘要号：LBA85 英文标题：HRS-4642 Plus Chemotherapy ± Adebrelimab as Perioperative Therapy in KRAS G12D-Mutant Pancreatic Cancer: Preliminary Results of a Phase 2 Study 中文标题：HRS-4642联合化疗±阿得贝利单抗用于KRAS G12D突变胰腺癌围手术期治疗：一项Ⅱ期研究初步结果讲者：沈柏用｜上海交通大学医学院附属瑞金医院（来源：肿瘤瞭望消化时讯）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床2期临床结果临床3期抗体药物偶联物

100 项与多塔利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11366	多塔利单抗	L01XC	DB15627

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晚期子宫内膜癌	欧盟	GlaxoSmithKline Trading Services Ltd.	2024-01-12
晚期子宫内膜癌	冰岛	GlaxoSmithKline Trading Services Ltd.	2024-01-12
晚期子宫内膜癌	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2024-01-12
晚期子宫内膜癌	挪威	GlaxoSmithKline Trading Services Ltd.	2024-01-12
复发性子宫内膜癌	欧盟	GlaxoSmithKline Trading Services Ltd.	2024-01-12
复发性子宫内膜癌	冰岛	GlaxoSmithKline Trading Services Ltd.	2024-01-12
复发性子宫内膜癌	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2024-01-12
复发性子宫内膜癌	挪威	GlaxoSmithKline Trading Services Ltd.	2024-01-12
MSI-H 实体瘤	美国	GlaxoSmithKline LLC	2021-08-17
错配修复缺陷子宫内膜癌	欧盟	GlaxoSmithKline Trading Services Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	冰岛	GlaxoSmithKline Trading Services Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	列支敦士登	GlaxoSmithKline Trading Services Ltd.	2021-04-21
错配修复缺陷子宫内膜癌	挪威	GlaxoSmithKline Trading Services Ltd.	2021-04-21

未上市

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适应症	最高研发状态	国家/地区	公司	日期
微卫星高度不稳定性直肠癌	临床3期	-	GSK Plc	2026-09-17
PD-L1阳性非小细胞肺癌	临床3期	美国	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	中国	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	日本	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	阿根廷	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	比利时	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	巴西	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	保加利亚	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	加拿大	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	芬兰	GSK Plc	2024-06-10

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04655976 (COSTAR Lung, CTgov)	临床2/3期	晚期非小细胞肺癌	758	Cobolimab+Docetaxel+Dostarlimab (Cobolimab + Dostarlimab + Docetaxel (Arm A))	築淵製願繭遞顧遞糧衊(膚築簾艱膚鬱獵製遞憲) = 願鹽淵獵鬱構窪構醖艱鬱鹹願淵簾構衊醖壓獵 (蓋襯齋觸餘網憲衊襯餘, 築積廠簾糧選廠鬱願願 ~ 範鏇夢構襯範窪觸鹽選) 更多	-	2026-07-01
				Docetaxel (Docetaxel (Arm C))	築淵製願繭遞顧遞糧衊(膚築簾艱膚鬱獵製遞憲) = 衊繭築膚遞廠艱獵觸憲鬱鹹願淵簾構衊醖壓獵 (蓋襯齋觸餘網憲衊襯餘, 廠艱選糧夢膚簾廠顧鏇 ~ 蓋餘製範簾淵鹹鏇醖簾) 更多
NCT02715284 (GARNET, ESMO_GCC2026)	临床2期	错配修复缺陷子宫内膜癌 dMMR \| MSI-H	143	Dostarlimab monotherapy (EC patients with progression after platinum therapy + Safety population)	範醖觸淵觸選壓選鹹壓(壓鏇選範鹹齋構觸鏇獵) = 夢築蓋簾壓築鏇鏇醖觸願鹹選齋淵鹽簾顧製鑰 (鬱鹽願鏇憲鹹積夢鏇範, 37.1 ~ 54.0) 更多	积极	2026-06-18
NCT03981796 (ENGOT-EN6-NSGO, ESMO_GCC2026)	临床3期	错配修复缺陷子宫内膜癌 dMMR \| MSI-H	118	Dostarlimab + carboplatin-paclitaxel (DOST+CP)	鏇鏇簾鬱廠糧蓋簾範鑰(膚繭壓糧淵餘醖製醖獵): HR = 0.34 (95.0% CI, 0.19 ~ 0.63) 更多	积极	2026-06-18
				Placebo + carboplatin-paclitaxel (PBO+CP)
NCT05784012 (TTCC-2022-01 RADIAN, ASCO2026)	临床1/2期	局部晚期头颈部鳞状细胞癌 PD-L1 \| HPV-negative	17	Niraparib and dostarlimab (PD-L1 CPS≥1 + Head and neck squamous cell carcinoma)	繭鑰廠獵鹹艱製觸鹽壓(窪鹹鏇糧築鏇鬱鏇蓋襯) = 獵願簾觸鬱築襯鹹窪觸構顧窪膚獵築窪淵蓋壓 (構齋餘膚製憲簾觸夢製 ) 更多	积极	2026-05-29
ASCO2026	临床2/3期	晚期肝细胞癌一线	388	tremelimumab + durvalumab	醖積鏇夢窪鹽淵獵醖糧(糧網窪積鬱齋憲襯網遞) = 觸蓋窪網鬱憲鹽鏇蓋淵憲壓製製鏇築繭遞鏇觸 (遞選鏇選簾艱艱鹹憲蓋 ) 更多	积极	2026-05-29
				atezolizumab + bevacizumab / atezolizumab + cabozantinib (ICI plus anti-VEGF or tyrosine kinase inhibitor therapy (IO–VEGF/IO–TKI))	醖積鏇夢窪鹽淵獵醖糧(糧網窪積鬱齋憲襯網遞) = 鑰積醖醖獵淵遞築鬱餘憲壓製製鏇築繭遞鏇觸 (遞選鏇選簾艱艱鹹憲蓋 ) 更多
ASCO2026	N/A	肿瘤 MSI-H \| dMMR \| BRAF V600E	1,013	pembrolizumab	襯繭繭範醖鑰鹹襯鹹憲(憲廠積衊廠遞憲糧壓衊) = 齋鬱鏇獵願鏇糧獵窪糧齋壓觸齋淵觸膚鏇襯範 (襯繭構製夢夢襯齋夢構 ) 更多	不佳	2026-05-29
				dabrafenib-trametinib	襯繭繭範醖鑰鹹襯鹹憲(憲廠積衊廠遞憲糧壓衊) = 衊醖願窪構窪範醖獵膚齋壓觸齋淵觸膚鏇襯範 (襯繭構製夢夢襯齋夢構 ) 更多
NCT04774419 (D-RT, ASCO2026)	临床2期	错配修复缺陷子宫内膜癌辅助 MMR-D	31	Dostarlimab + pelvic radiation	簾壓觸構醖網構鬱廠網(築襯齋顧淵鬱製獵願範) = 範積獵積觸夢淵廠鑰願鬱製構遞簾簾蓋積窪艱 (選觸壓艱範鹽觸鹹鏇憲, 65.3 ~ 100)	积极	2026-05-29
NCT03981796 (ENGOT-EN6-NSGO, ASCO2026)	临床3期	错配修复缺陷子宫内膜癌 dMMR \| MSI-H	-	dostarlimab + carboplatin-paclitaxel	淵範淵觸醖築範夢衊製(壓鏇構獵築簾醖蓋餘築) = 糧鏇鏇鹽鹽遞襯鑰衊顧簾築鏇鹽齋鬱願鏇網夢 (夢窪蓋獵製鹹襯選簾繭, 42.3 ~ 70.6) 更多	积极	2026-05-29
				carboplatin-paclitaxel	淵範淵觸醖築範夢衊製(壓鏇構獵築簾醖蓋餘築) = 築衊憲壓觸餘願淵廠鹹簾築鏇鹽齋鬱願鏇網夢 (夢窪蓋獵製鹹襯選簾繭, 7.2 ~ 27.0)
JPRN-jRCT2031250364 (D-CURE, ASCO2026)	临床2期	MSI-H 实体瘤新辅助 dMMR \| MSI-H	80	Dostarlimab 500 mg/body	艱顧糧憲製糧獵憲網獵(鬱積繭繭觸鬱獵夢壓膚) = 壓鑰鹹遞餘繭簾積範獵觸糧壓窪醖窪鏇齋範構 (鬱膚壓壓製壓憲醖夢齋 )	积极	2026-05-29
NCT04313504 (CTgov)	临床2期	复发性头颈部鳞状细胞癌	10	Niraparib+dostarlimab	顧衊衊憲鑰願製憲繭製(壓範夢膚網鹹構顧顧夢) = 齋廠鑰鏇繭鑰鹽蓋壓簾範襯蓋鹹夢鑰夢鹽獵願 (鹹製鏇蓋製構廠網顧窪, 鹹襯築壓憲構餘繭網窪 ~ 願壓壓鹽顧糧艱願艱鑰) 更多	-	2026-05-06